W L Gore & Associates, Inc. Recall 88721
Description: Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
W L Gore & Associates, Inc. Recall 88721 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0077-2022 |
Event ID | 88721 |
Event Description | Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI: |
Product Type | Devices |
Distribution | International distribution to the countries of Italy & Lebanon. |
Quantity | 2 units |
Recall Reason | Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device. |
Device Classification | 20211020 |
Device Code Info | Serial Numbers: 22753580 |
Center Classification Date | 20211008 |
Recall Initiation Date | 20210907 |
Recalling Firm | W L Gore & Associates, Inc. |
Initial Notification | |
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